WO2018024646A1 - Composé pharmaceutique comprenant du céfuroxime. - Google Patents

Composé pharmaceutique comprenant du céfuroxime. Download PDF

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Publication number
WO2018024646A1
WO2018024646A1 PCT/EP2017/069242 EP2017069242W WO2018024646A1 WO 2018024646 A1 WO2018024646 A1 WO 2018024646A1 EP 2017069242 W EP2017069242 W EP 2017069242W WO 2018024646 A1 WO2018024646 A1 WO 2018024646A1
Authority
WO
WIPO (PCT)
Prior art keywords
pomalidomide
composition according
maltodextrin
filler
pharmaceutical composition
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/EP2017/069242
Other languages
English (en)
Inventor
Sonia GARCIA JIMENEZ
Luis Nogueiras Nieto
Lisardo ÁLVAREZ FERNÁNDEZ
Jose VELADA CALZADA
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Synthon BV
Original Assignee
Synthon BV
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Synthon BV filed Critical Synthon BV
Priority to US16/322,571 priority Critical patent/US11517536B2/en
Priority to RU2019105711A priority patent/RU2019105711A/ru
Priority to EP17749418.4A priority patent/EP3493791A1/fr
Publication of WO2018024646A1 publication Critical patent/WO2018024646A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/454—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds

Definitions

  • Pomalidomide chemically 4-amino-2-(2,6-dioxopiperidin-3-yl)isoindole-l,3-dione of formula (I),
  • Pomalidomide is marketed by Celgene under the brand names Imnovid ® and Pomalyst ® .
  • Imnovid ® and Pomalyst ® are supplied for oral administration, as immediate- release hard gelatin capsules in four different strengths: 1, 2, 3 and 4 mg.
  • Pomalidomide is a BCS class IV product, having low permeability and low solubility.
  • the drug substance is practically insoluble in water.
  • WO2010135396 discloses the marketed formulation of Imnovid ® and Pomalyst ® containing, besides pomalidomide, pregelatinized starch, mannitol and sodium stearyl fumarate. It contains pomalidomide polymorph A.
  • the primary packaging of the capsules is polyvinyl chloride (PVC)/polychlorotrifluoroethylene (PCTFE) blisters with push through aluminium foil. These blisters provide a high moisture barrier, but are expensive.
  • the capsule strengths use two common blends comprising the same excipients, varying in the proportion of drug substance and the two excipients mannitol and sodium stearyl fumarate.
  • the capsules comprising 1 and 2 mg of pomalidomide are dose proportional and utilize a common blend.
  • the capsules comprising 3 and 4 mg of pomalidomide are dose proportional and use another common blend.
  • CN 104042590 discloses capsule formulations comprising pomalidomide, anhydrous lactose, dextrin, cross-linked sodium carboxymethyl cellulose and polyethylene glycol 4000. It describes the use of two common blends: one blend for the 1 and 2 mg capsules and a second common blend for the 3 and 4 mg capsules. The capsules show good stability at 25°C/60% RH in non-specified packaging material.
  • CN104224723 discloses pomalidomide nanoparticles comprising 0.5 to 1.5% by weight of pomalidomide. To obtain the nanoparticles, specific equipment is needed which is not present in most pharmaceutical production plants. No stability data of the obtained compositions is presented.
  • CN 104523692 discloses complexes of pomalidomide and cyclodextrins, obtained by freeze-drying.
  • the technique of freeze-drying requires specific equipment and is rather expensive.
  • compositions comprising pomalidomide, which exhibit excellent long term stability and which are suitable for production on commercial scale by applying techniques and equipment commonly used in industry. It would be advantageous if, in addition, these compositions would require the use of just one common blend for the proposed capsule strengths.
  • the present invention provides a pharmaceutical composition
  • a pharmaceutical composition comprising
  • pomalidomide pomalidomide, maltodextrin and a filler, wherein the weight ratio of maltodextrin to filler ranges from 1: 1 to 1:2. It also provides a process to prepare said composition in the form of a capsule by blending pomalidomide and excipients followed by encapsulation.
  • Said pharmaceutical composition may be used as medicament in the treatment of multiple myeloma.
  • the marketed formulation of Imnovid ® and Pomalyst ® contains, besides pomalidomide, pregelatinized starch, mannitol and sodium stearyl fumarate.
  • the first formulation developed contained anhydrous lactose, microcrystalline cellulose, croscarmellose sodium and magnesium stearate.
  • anhydrous lactose was replaced with anhydrous dibasic calcium phosphate and other excipients were changed accordingly.
  • the revised formulation contained pomalidomide, anhydrous dibasic calcium phosphate, pregelatinized starch, croscarmellose sodium and sodium stearyl fumarate.
  • Pomalidomide exhibits potential reactivity towards fillers like maltose, lactose, trehalose or glucose, e.g. mono- or disaccharides, via a Maillard reaction.
  • fillers like maltose, lactose, trehalose or glucose, e.g. mono- or disaccharides, via a Maillard reaction.
  • pomalidomide is prone to reaction with nucleophiles like calcium phosphate and sodium bicarbonate by a type of Gabriel reaction.
  • the primary packaging of the marketed capsules is polyvinyl chloride
  • PVC polyvinyl chloride
  • PCTFE polychlorotrifluoroethylene
  • the marketed formulation is available as immediate-release hard gelatin capsules in four different strengths: 1, 2, 3 and 4 mg.
  • the capsule strengths are manufactured using two common blends comprising the same excipients, varying in the proportion of drug substance and the two excipients mannitol and sodium stearyl fumarate.
  • the capsules comprising 1 and 2 mg of pomalidomide are dose proportional and utilize one single common blend.
  • the capsules comprising 3 and 4 mg of pomalidomide are dose proportional and use another common blend. It would be advantageous to have a pharmaceutical composition comprising pomalidomide enabling the use of just one blend for all capsule strengths.
  • compositions of the present invention are more stable in less protective packaging material when compared to the marketed pomalidomide capsules.
  • Maltodextrin is a saccharide mixture of polymers that consist of D-glucose units, with a dextrose equivalent (DE) less than 20.
  • DE dextrose equivalent
  • the solubility, hygroscopicity and compressibility of maltodextrin increase as the DE increases.
  • any maltodextrin can be used in accordance with the present invention.
  • maltodextrin with a DE of 11 to 14 is selected because of its good flow properties and acceptable bulk density.
  • a typical example of such a grade of maltodextrin is Glucidex 12 or Glucidex IT12.
  • the pharmaceutical composition of the present invention comprises, besides pomalidomide and maltodextrin, a filler.
  • the weight ratio of maltodextrin to the filler ranges from 1: 1 to 1:2. More preferably, the weight ratio of maltodextrin to the filler ranges from 1: 1.2 to 1: 1.5.
  • the filler is selected from microcrystalline cellulose and calcium lactate. Calcium lactate can exist in a number of hydration states. In pharmaceutical compositions, calcium lactate is preferably used in its pentahydrated form as filler. More preferably, the filler used in accordance with the present invention is microcrystalline cellulose. Different grades of microcrystalline cellulose can be used. Most preferably, a type of microcrystalline cellulose with increased bulk density is used, allowing a reduction in blend volumes.
  • a typical example of such a grade of microcrystalline cellulose is Vivapur ® 301 or Vivapur ® 302.
  • the amount of pomalidomide in the pharmaceutical composition in accordance with the present invention is more than 2% by weight based on the total weight of the composition.
  • the pharmaceutical composition according to the present invention requires just one single blend for all capsule strengths while the same capsule size as the Imnovid ® and Pomalyst ® capsules can be employed. The production process is simpler and the costs are reduced in case all capsule strengths are dose proportional.
  • Pomalidomide in accordance with the present invention has a particle size distribution D90 equal to or less than 15 ⁇ . With increasing D90 values, the dissolution is slowing down rapidly.
  • the pharmaceutical composition of the present invention comprising pomalidomide, maltodextrin and a filler, further comprises one or more pharmaceutically acceptable excipients.
  • the excipients to be used in accordance with the present invention are well- known and are those excipients which are conventionally used by the person skilled in the art. Depending on the dosage form chosen for the pharmaceutical composition, the person skilled in the art will be able to select suitable pharmaceutically acceptable excipients.
  • the pharmaceutical composition is in the form of a capsule. Most preferably, the capsule is a hard gelatin capsule.
  • the pharmaceutical composition of the present invention further comprises, besides pomalidomide, maltodextrin and a filler, a lubricant and optionally a disintegrant.
  • the lubricant to be used in accordance with the present invention may be any lubricant known to a person of ordinary skill in the art.
  • Sodium stearyl fumarate is a particularly preferred lubricant.
  • disintegrant in the composition depends upon the choice of filler. Some fillers, like microcrystalline cellulose, do possess disintegrating properties. In case such a filler is used, there is no need to include a disintegrant in the pharmaceutical composition. On the other hand, in the event that calcium lactate is used as filler, a disintegrant is required.
  • the disintegrant to be used in accordance with the present invention may be any disintegrant known to a person of ordinary skill in the art. Suitable disintegrants to be used in accordance with the present invention are selected from the group consisting of croscarmellose sodium, crospovidone or sodium starch glycolate. Croscarmellose sodium is a particularly preferred disintegrant.
  • the pharmaceutical composition in accordance with the present invention exhibits a dissolution rate of at least 65% in 15 minutes and at least 90% in 45 minutes when tested in aqueous hydrochloric acid 0.1 N in a USP apparatus II at 50-100 rpm, 37°C.
  • the pharmaceutical composition of the present invention exhibits excellent long term stability. It is significantly less sensitive to moisture than the commercial products Imnovid ® and Pomalyst ® and therefore does not require expensive high moisture barrier packaging material like polyvinyl chloride (PVC)/polychlorotrifluoroethylene (PCTFE) blisters.
  • PVC polyvinyl chloride
  • PCTFE polychlorotrifluoroethylene
  • the dissolution profile of the capsules mimic the profile of the Imnovid ® and Pomalyst ® capsules.
  • the pharmaceutical composition of the present invention is very suitable for production on commercial scale making use of equipment and techniques commonly used in industry.
  • the pharmaceutical composition of the present invention in the form of a capsule is obtained by a process comprising blending pomalidomide and excipients followed by encapsulation, using equipment and methods well-known in the art.
  • the pharmaceutical composition in accordance with the present invention may be used as a medicament.
  • the pharmaceutical composition typically may be used in the treatment of multiple myeloma.
  • Reference example 1 Pharmaceutical composition Imnovid ® /Pomalyst ®
  • Imnovid ® /Pomalyst ® capsules have the composition as given in table 1. Table 1
  • the pomalidomide and mannitol were sieved through a suitable mesh sieve for deagglomeration and mixed in a suitable tumbling mixer.
  • Pregelatinized starch was sieved through a suitable mesh sieve for deagglomeration, added to the blend and mixed in the tumbling mixer.
  • Sodium stearyl fumarate was sieved through a suitable mesh sieve to deagglomerate, added to the blend and mixed in the tumbling mixer.
  • the homogeneous blend was encapsulated using a dosator capsule filling machine. The hard gelatin capsules were packed and stored at 40°C/75 RH.
  • Example 1 Pharmaceutical composition comprising pomalidomide,
  • the capsules comprising pomalidomide, microcrystalline cellulose and maltodextrin have the composition as given in table 2.
  • Table 2 The capsules comprising pomalidomide, microcrystalline cellulose and maltodextrin have the composition as given in table 2.
  • the pomalidomide and microcrystalline cellulose were sieved through a suitable mesh sieve for deagglomeration and mixed in a suitable tumbling mixer.
  • Maltodextrin (Glucidex IT 12) was sieved through a suitable mesh sieve for deagglomeration, added to the blend and mixed in the tumbling mixer.
  • Sodium stearyl fumarate was sieved through a suitable mesh sieve to deagglomerate, added to the blend and mixed in the tumbling mixer.
  • the homogeneous blend was encapsulated using a dosator capsule filling machine.
  • the hard gelatin capsules were packed and stored at 40°C/75% RH.
  • the capsules obtained exhibited a dissolution rate of at least 65% in 15 minutes and at least 90% in 45 minutes when tested in aqueous hydrochloric acid 0.1 N in a USP apparatus II at 100 rpm, 37°C.
  • the dissolution profile of the capsules is similar to the profile of Imno vid ® /Pomaly st ® .
  • the capsules obtained are bioequivalent to the Imnovid ® /Pomalyst ® capsules.
  • Example 2 Pharmaceutical composition comprising pomalidomide, calcium lactate and maltodextrin
  • the capsules comprising of pomalidomide, calcium lactate and maltodextrin have the composition as given in table 3.
  • the pomalidomide, maltodextrin (Glucidex IT 12), calcium lactate pentahydrate and croscarmellose sodium were sieved through a suitable mesh sieve for deagglomeration and mixed in a suitable tumbling mixer.
  • Sodium stearyl fumarate was sieved through a suitable mesh sieve to deagglomerate, added to the blend and mixed in the tumbling mixer.
  • the homogeneous blend was encapsulated using a dosator capsule filling machine.
  • the hard gelatin capsules were packed and stored at 40°C/75% RH.
  • the capsules obtained exhibited a dissolution rate of at least 65% in 15 minutes and at least 90% in 45 minutes when tested in aqueous hydrochloric acid 0.1 N in a USP apparatus II at 50 rpm, 37°C.
  • the dissolution profile of the capsules is similar to the profile of Imno vid ® /Pomaly st ® .
  • Example 4 Stability results
  • Table 4 Stability results at 40°C/75% RH for Imnovid ® /Pomalyst ® capsules composition (4 mg/capsule) prepared according to Reference example 1 in different packaging materials
  • Table 5 Stability results at 40°C/75% RHfor capsules (4 mg/capsule) prepared according to example 1 (comprising pomalidomide, micwcrystalline cellulose and maltodextrin) in different packaging materials
  • Table 6 Stability results at 40°C/75% RHfor capsules (4 mg/capsule) prepared according to example 1 (comprising pomalidomide, micwcrystalline cellulose and maltodextrin) in different packaging materials

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L'invention porte sur un composé pharmaceutique comprenant du pomalidomide, de la maltodextrine et un excipient. Le rapport pondéral de la maltodextrine par rapport à l'excipient est compris entre 1:1 et 1:2. Ce composé peut être utilisé comme médicament, notamment dans le traitement de l'incontinence urinaire.
PCT/EP2017/069242 2016-08-02 2017-07-28 Composé pharmaceutique comprenant du céfuroxime. Ceased WO2018024646A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
US16/322,571 US11517536B2 (en) 2016-08-02 2017-07-28 Pharmaceutical composition comprising pomalidomide
RU2019105711A RU2019105711A (ru) 2016-08-02 2017-07-28 Фармацевтическая композиция, содержащая помалидомид
EP17749418.4A EP3493791A1 (fr) 2016-08-02 2017-07-28 Composé pharmaceutique comprenant du céfuroxime.

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP16182389 2016-08-02
EP16182389.3 2016-08-02

Publications (1)

Publication Number Publication Date
WO2018024646A1 true WO2018024646A1 (fr) 2018-02-08

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PCT/EP2017/069242 Ceased WO2018024646A1 (fr) 2016-08-02 2017-07-28 Composé pharmaceutique comprenant du céfuroxime.

Country Status (4)

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US (1) US11517536B2 (fr)
EP (1) EP3493791A1 (fr)
RU (1) RU2019105711A (fr)
WO (1) WO2018024646A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3545949A1 (fr) * 2018-03-29 2019-10-02 Midas Pharma GmbH Formes posologiques orales comprenant une forme cristalline a de pomalidomide
WO2021209919A1 (fr) * 2020-04-15 2021-10-21 TECNIMEDE - Sociedade Técnico-medicinal, SA Forme posologique orale solide comprenant de la pomalidomide
EA039874B1 (ru) * 2019-06-06 2022-03-22 Общество С Ограниченной Ответственностью "Технология Лекарств" Композиция помалидомида для лечения заболеваний, ассоциированных с фактором некроза опухоли (фно)
EP4233849A1 (fr) 2022-02-25 2023-08-30 KRKA, d.d., Novo mesto Composition pharmaceutique comprenant du pomalidomide

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010135396A2 (fr) 2009-05-19 2010-11-25 Celgene Corporation Préparations de 4-amino-2-(2,6-dioxopipéridine-3-yl)isoindoline-1,3-dione
CN104042590A (zh) 2014-07-02 2014-09-17 南京卡文迪许生物工程技术有限公司 一种稳定的泊马度胺胶囊剂及其制备方法
CN104224723A (zh) 2014-10-14 2014-12-24 北京科莱博医药开发有限责任公司 一种泊马度胺纳米粒、制剂及其制备方法
CN104523692A (zh) 2014-12-16 2015-04-22 南京艾德凯腾生物医药有限责任公司 一种泊马度胺复合物及其制备方法
US20160039785A1 (en) * 2013-03-26 2016-02-11 Celgene Corporation Solid forms comprising 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione and a coformer, compositions and methods of use thereof

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010135396A2 (fr) 2009-05-19 2010-11-25 Celgene Corporation Préparations de 4-amino-2-(2,6-dioxopipéridine-3-yl)isoindoline-1,3-dione
US20160039785A1 (en) * 2013-03-26 2016-02-11 Celgene Corporation Solid forms comprising 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione and a coformer, compositions and methods of use thereof
CN104042590A (zh) 2014-07-02 2014-09-17 南京卡文迪许生物工程技术有限公司 一种稳定的泊马度胺胶囊剂及其制备方法
CN104224723A (zh) 2014-10-14 2014-12-24 北京科莱博医药开发有限责任公司 一种泊马度胺纳米粒、制剂及其制备方法
CN104523692A (zh) 2014-12-16 2015-04-22 南京艾德凯腾生物医药有限责任公司 一种泊马度胺复合物及其制备方法

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3545949A1 (fr) * 2018-03-29 2019-10-02 Midas Pharma GmbH Formes posologiques orales comprenant une forme cristalline a de pomalidomide
WO2019185862A1 (fr) * 2018-03-29 2019-10-03 Midas Pharma GmbH Formes posologiques orales comprenant une forme a cristalline de pomalidomide
EA039874B1 (ru) * 2019-06-06 2022-03-22 Общество С Ограниченной Ответственностью "Технология Лекарств" Композиция помалидомида для лечения заболеваний, ассоциированных с фактором некроза опухоли (фно)
WO2021209919A1 (fr) * 2020-04-15 2021-10-21 TECNIMEDE - Sociedade Técnico-medicinal, SA Forme posologique orale solide comprenant de la pomalidomide
EP4233849A1 (fr) 2022-02-25 2023-08-30 KRKA, d.d., Novo mesto Composition pharmaceutique comprenant du pomalidomide

Also Published As

Publication number Publication date
EP3493791A1 (fr) 2019-06-12
US20190183805A1 (en) 2019-06-20
RU2019105711A (ru) 2020-09-04
US11517536B2 (en) 2022-12-06
RU2019105711A3 (fr) 2020-09-21

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